POLIOMYELITIS VACCINE SUSPENSION FOR INJECTION

País: Xipre

Idioma: grec

Font: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

ingredients actius:

INACTIVATED POLIOMYELITIS VACCINE TYPE 1(MAHONEY); INACTIVATED POLIOMYELITIS VACCINE TYPE 2(MEF-1); INACTIVATED POLIOMYELITIS VACCINE TYPE 3(SAUKETT)

Disponible des:

BILTHOVEN BIOLOGICALS B.V. (0000012092) ANTONIE VAN LEEUWENHOEKLAAN 9-13, MA BILTHOVEN, 3721

Codi ATC:

J07BF03

Designació comuna internacional (DCI):

POLIOMYELITIS, TRIVALENT, INACTIVATED, WHOLE VIRUS

formulario farmacéutico:

SUSPENSION FOR INJECTION

Composición:

INACTIVATED POLIOMYELITIS VACCINE TYPE 1(MAHONEY) (8000003623) 40U; INACTIVATED POLIOMYELITIS VACCINE TYPE 2(MEF-1) (8000003624) 8U; INACTIVATED POLIOMYELITIS VACCINE TYPE 3(SAUKETT) (8000003626) 32U

Vía de administración:

ΥΠΟΔΟΡΙΑ ΧΡΗΣΗ; INTRAMUSCULAR USE

tipo de receta:

Ειδική άδεια άρθρο 126A

Resumen del producto:

Νομικό καθεστώς: Με Ιατρική Συνταγή; PACK WITH 1 VIAL X 0.5ML () 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή

Informació per a l'usuari

SHELF LIFE
The shelf life is 36 months.
SPECIAL PRECAUTIONS DURING STORAGE
The vaccine requires a storage temperature between 2 and 8°C. Do not
freeze.
After opening a multidose vial (containing 5 doses) store between 2
and
8°C and use within 28 days.
PACKAGING
The vaccine is filled in vials (type 1 hydrolytic glass) and sealed
with a
rubber stopper (free of latex) and an aluminium flip-off cap and
contains
0.5 mL vaccine (single dose) or 2.5 mL vaccine (multidose).
SPECIAL INSTRUCTIONS FOR USE AND DISPOSAL.
NAME
POLIOMYELITIS VACCINE
PACKAGE LEAFLET: INFORMATION FOR THE USER
No specific requirements.
VACCINE VIAL MONITOR (IF PRESENT ON THE VIAL):
The Vaccine Vial Monitor (VVM) is present on the vial in the form of a
colour dot. This is a time-temperature sensitive dot that provides an
indication of the cumulative heat to which the vial has been exposed.
It
warns the end user when exposure to heat is likely to have degraded
the
vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square.
Its
colour will change progressively. As long as the colour of this square
is
lighter than the colour of the ring, the vaccine can be used. As soon
as the
colour of the central square is the same colour as the ring or
darker, the vial should be discarded.
MARKETING AUTHORIZATION HOLDER
Bilthoven Biologicals B.V.
Antonie van Leeuwenhoeklaan 9-13
3721 MA Bilthoven
The Netherlands
Telephone [phone]
MARKETING LICENSE
Poliomyelitis vaccine is licensed in the Netherlands under number RVG
17642
Poliomyelitis vaccine multidose is licensed in the Netherlands under
number RVG 114720
DATA OF FIRST LICENSE OR LICENSE RENEWAL
First license monodose; December 2
nd
, 1993
License renewal; August 25
th
, 1994
First license multidose (5-dose): November 12
th
, 2014
VERSION
WHO package insert, version August 2020
Poliomyelitis vaccine, suspension for injection
COMPOSITION
One dose of 0.5 mL poliomyelitis vaccine contains the following active
components:
Inactivated poliomyelitis virus type 1